Actively Recruiting
CHOP Plus Mosunetuzumab as First Line in Patients With Richter´s Syndrome: a Phase II Study of the Spanish Group of CLL
Led by GELLC (Grupo Español de Leucemia Linfocítica Crónica) · Updated on 2025-04-13
34
Participants Needed
16
Research Sites
208 weeks
Total Duration
On this page
Sponsors
G
GELLC (Grupo Español de Leucemia Linfocítica Crónica)
Lead Sponsor
E
Evidenze CRO
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if drug Mosunetuzumab works to treat Richter´syndrome . It will also learn about the safety of drug Mosunetuzumab. The main questions it aims to evaluate the efficacy of mosunetuzumab combined with CHOP (M-CHOP) after the end of induction in patients with Richter´s Syndrome who have never received thearapy What medical problems do participants have when taking drug Mosunetuzumab? Patients with Richter´s Syndrome Participants will: Take drug Mosunetuzumab+CHOP during 6 cycle and they if they are not candidate to Alothasplant continuing 11 cycles more with mosunetuzumab on monoterapy Visit the clinic once every 23weeks for checkups and tests
CONDITIONS
Official Title
CHOP Plus Mosunetuzumab as First Line in Patients With Richter´s Syndrome: a Phase II Study of the Spanish Group of CLL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give signed informed consent
- Aged between 18 and 79 years at consent
- Able to follow study procedures and hospital visits
- ECOG performance status of 2 or less
- Adult patients with untreated, histologically confirmed Richter's syndrome, diffuse large B cell variant
- CD20 positive disease confirmed by testing
- Adequate bone marrow function not due to leukemia involvement
- Platelet count at least 75 x 10^9/L (or 30 x 10^9/L if low due to marrow involvement)
- Absolute neutrophil count at least 1 x 10^9/L unless due to marrow involvement
- Hemoglobin 9 g/dL or higher unless due to marrow involvement
- Creatinine clearance 45 mL/min or higher
- Life expectancy longer than 3 months
- Women of childbearing potential agree to use effective contraception or abstain during and for 3 months after treatment
- Men agree to use condom or abstain during and for specified periods after treatment
You will not qualify if you...
- Pregnant or breastfeeding or planning pregnancy during or within 3 months after treatment
- Prior treatment with Mosunetuzumab or other CD20/CD3 bispecific antibodies
- Recent autologous stem cell transplant within 100 days
- Allogeneic stem cell transplant for CLL
- CAR T-cell therapy within 100 days prior to treatment
- Use of systemic corticosteroids over 20 mg/day prednisone equivalent for more than 5 days before treatment
- Central nervous system involvement by disease
- Transformation of CLL to prolymphocytic leukemia
- History of prior malignancy unless disease-free for 2 years or specific exceptions
- Laboratory abnormalities including low creatinine clearance, low neutrophils or platelets (unless due to marrow involvement), elevated liver enzymes, or high bilirubin
- Severe allergic reactions to monoclonal antibody therapy
- Contraindication to tocilizumab
- Active autoimmune disorders at time of first dose
- History of autoimmune diseases except controlled hypothyroidism or type 1 diabetes
- History of solid organ transplant
- Recent serious infections or active infections at enrollment
- History of progressive multifocal leukoencephalopathy
- Positive HIV test
- Chronic hepatitis B or C infection not controlled
- Known or suspected chronic active Epstein Barr Virus infection
- History of macrophage activation syndrome or hemophagocytic lymphohistiocytosis
- Recent live attenuated vaccine within 4 weeks before treatment
- Left ventricular ejection fraction under 50%
- Significant cardiovascular, pulmonary, liver, or central nervous system disease
- Recent major surgery within 4 weeks before treatment
- Dependence on Sponsor or investigator
- Any serious medical condition preventing safe participation or completion of the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Hospital Vall Hebron
Barcelona, Barcelona, Spain, 08035
Actively Recruiting
2
Hospital Clínic y Porvincial de Barcelona
Barcelona, Barcelona, Spain, 08036
Actively Recruiting
3
ICO Hospitalet Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Actively Recruiting
4
H Marqués de Valdecilla
Santander, Cantabria, Spain, 39011
Actively Recruiting
5
Complejo Hospitalario Universitario de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain, 35010
Active, Not Recruiting
6
Hospital Universitario La Princesa
Madrid, Madrid, Spain, 28006
Actively Recruiting
7
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain, 28041
Actively Recruiting
8
Hospital General Universitario Morales Meseguer
Murcia, Murcia, Spain, 30008
Active, Not Recruiting
9
Hospital Universitario Costa del Sol
Marbella, Málaga, Spain, 29603
Active, Not Recruiting
10
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain, 33011
Actively Recruiting
11
Hospital Universitario de Salamanca
Salamanca, Salamanca, Spain, 37007
Active, Not Recruiting
12
Hospital de Donostia
Donostia / San Sebastian, San Sebastian, Spain, 20014
Actively Recruiting
13
Centro Hospitalario Universitario de Santiago
Santiago de Compostela, Santiago de Compostela, Spain, 15706
Actively Recruiting
14
Hospital Universitario Virgen del Rocío
Seville, Sevilla, Spain, 41013
Active, Not Recruiting
15
Hospital Universitario Clínico de Valencia
Valencia, Valencia, Spain, 46010
Active, Not Recruiting
16
Hospital Universitario Lozano Blesa
Zaragoza, Zaragoza, Spain, 50009
Active, Not Recruiting
Research Team
A
Ana Méndez, Sponsor representative
CONTACT
T
Teresa Pascual Tome, CRO representative
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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